[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2012]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D--FDA Action on Applications and Abbreviated Applications Sec. 314.110 Complete response letter to the applicant.
(a)Complete response letter . FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in 314.125 or 314.127, respectively.
(1)Description of specific deficiencies . A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application, except as stated in paragraph (a)(3) of this section.
(2)Complete review of data . A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.
(3)Inadequate data . If FDA determines, after an application is filed or an abbreviated application is received, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling.
(4)Recommendation of actions for approval . When possible, a complete response letter will recommend actions that the applicant might take to place the application or abbreviated application in condition for approval.
(b)Applicant actions . After receiving a complete response letter, the applicant must take one of following actions:
(1)Resubmission . Resubmit the applicati
Yes. Read it already. I think most people are expecting a PDFUA date to be set out 6 months from APPA's upcoming response. Instead, as possible under the CFR's, I believe they will set it out for 2 months. These are small modifications for APPA, and they have every incentive to move rapidly....
In other words, I think people will be waiting for the next PDFUA date, when instead, a decision by the FDA, if it comes, to call this a Class 1 -- 2 month review, is a 99.99999% indication it will be approved.. imo.. By the time the PDFUA date arrives, the price will already reflect fully anticipated approval. If it is not labled a Class 1 review, then the price will be in limbo for a long time.
Incentives for company to move much faster.
1.avoid cash burn
2Avoid more stock dilution
3 Avoid other phase 3 CINV products coming online in 2015 or soon thereafter.
4. Avoid Patents on biochr. technology to languish needlessly.
5. Help patients.
6. Return to development of potentially hundreds of long release drugs.
7. sales force team was gearing up already.
8. APPA is basically assured approval, therefore it can afford to Manufacture and test their mass produced "commercial" syringe -- as opposed to independently built ones. This means that they will have already literally started their commercial manufacturing business before approval, which means they will launch their products at warp speed.
9. Medicare reimbursement and other incentives could disappear, via legislation, if APPA does not hurry.
Almost every "new" product that APPA will be involved in will be under 505B. Which means faster approval. Because this is the entry candidate, future long acting medications will be approved at a very high rate of speed.